510(k) · Cleared
ClearedCeribell Brain Monitor Headband
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceribell, Inc. · GXY Electrode, Cutaneous
Cleared on Apr 3, 2026 as substantially equivalent to K254033 (Ceribell, Inc., 2026) and 1 other predicate after a 58-day review. Its family tree reaches back 8 generations to 1978.
- Decided
- Apr 3, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K780045 (1978). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 7 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 6 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 5 generations backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- 4 generations backK200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020
- 3 generations backK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- 2 generations backK232052 Ceribell Instant EEG HeadbandCeribell, Inc. · 2023
- 1 generation backK254033 Ceribell Instant EEG HeadsetCeribell, Inc. · 2026
- This deviceK260363 Ceribell Brain Monitor HeadbandCeribell, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −7 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −6 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| −5 | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| −4 | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty, Ltd. | 2020 | — |
| −3 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| −2 | K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023 | — |
| −1 | K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 2026 | — |
| 0 (this device) | K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K254033 | Ceribell Instant EEG Headset Cleared while this submission was under review Summary page 5…Cutaneous electrode (21 CFR 882.1320) Device Class: II Product Code: GXY 3. PREDICATE DEVICE Primary: Ceribell Instant EEG Headset, K254033 Secondary: Ceribell Instant EEG Headband, K232052 4. DEVICE DESCRIPTION The Ceribell Brain Monitor Headband is a single-use, n… | 2026 |
| * | K232052 | Ceribell Instant EEG HeadbandSummary page 5…evice Class: II Product Code: GXY 3. PREDICATE DEVICE Primary: Ceribell Instant EEG Headset, K254033 Secondary: Ceribell Instant EEG Headband, K232052 4. DEVICE DESCRIPTION The Ceribell Brain Monitor Headband is a single-use, non-sterile, disposable EEG electrode device that i… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 48 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The Ceribell Brain Monitor Headband is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260363 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260363: Ceribell Brain Monitor Headband.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260363
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026